Advertisement

Topics

FDAnews Announces: Limited Seats Remaining for Understanding and Implementing EU Medical Device Regulation Workshop, July 11-12, 2017

03:00 EDT 23 Jun 2017 | PR Web

The EU has up-ended its rules and replaced the current three directives with two new regulations that are much tougher and promise to transform the way manufacturers do business abroad. FDAnews has teamed up with Ombu Enterprises Inc. to present a two-day workshop that brings manufacturers current with all the new rules and readies them to comply before the MDR and IVDR take effect.

Falls Church, VA (PRWEB) June 23, 2017

Understanding and Implementing EU Medical Device Regulation
**Presented by FDAnews and Ombu Enterprises**
July 11-12, 2017, Cambridge, MA
http://www.fdanews.com/eumdreg

NOTE: There are a limited number of seats available for the workshop.

The EU has up-ended its device rules.

The Medical Device Regulation (MDR), which replaces the existing Medical Device Directive (MDD), is packed with new provisions, changes to existing ones, inclusions and exclusions. These changes include:

  • Manufacturers' entire product portfolios will need to be re-approved
  • But the rules for accrediting Notified Bodies (NB) aren’t even final yet
  • Standards just released, such as the ISO 13485:2016, will change again to align with the new MDR
  • Turnaround time for incident reporting will drop from 30 to only 15 days

And this barely scratches the surface.

Here’s how to cope.

Come to Boston July 11-12 for two intense days of:

  • Learning all that’s new and changed
  • Understanding how to comply
  • And, perhaps best of all, hands-on application with a product

In a special workshop feature, attendees will apply the MDR’s new provisions to one of their own products that currently has the CE Mark under the MDD (especially Annex II) and satisfies the U.S. UDI rule.

Workshop leader, Dan O’Leary of Ombu Enterprises LLC, is a favorite of thousands of conference attendees for his ability to simplify the most complex device-related topics.

Meet the Presenter:
Dan O’Leary, President, Ombu Enterprises, LLC
Dan has more than 30 years’ experience in quality, operations and program management in regulated industries including, aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Should Attend:

  • Quality Managers/Engineers
  • Risk Managers
  • Regulatory Affairs
  • Design Engineers
  • Supply Chain Managers
  • Production Managers/Engineers
  • Document Control Specialists
  • Marketing Managers
  • Clinical Managers
  • Clinical Evaluation Specialists
  • Export Compliance Managers

Conference Details:
Understanding and Implementing EU Medical Device Regulation
**Presented by FDAnews and Ombu Enterprises**
July 11-12, 2017, Cambridge, MA
http://www.fdanews.com/eumdreg

Tuition: $1,797
A limited number of seats are still available.

Easy Ways to Register:
Online: http://www.fdanews.com/eumdreg
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/eumdregulations/prweb14449946.htm

NEXT ARTICLE

More From BioPortfolio on "FDAnews Announces: Limited Seats Remaining for Understanding and Implementing EU Medical Device Regulation Workshop, July 11-12, 2017"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Medical Devices
The role of medical devices in healthcare is essential.  The diversity and innovativeness of this sector contribute significantly to enhance the quality and efficacy of healthcare.  Covering a wide range of products, from simple bandages to the...

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...